Stress Testing Protocol for Coronary Heart Disease

Overseen By Barbra Streisand Women's Heart Center

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Cardiovascular, Pulmonary, Neurological, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how small blood vessel issues in the heart, often causing chest pain, particularly in women, affect heart function. Researchers will use techniques such as altitude simulation and exercise (including leg exercise and handgrip) to stress the heart and capture detailed images for a better understanding of the condition. Participants will include women with known small vessel heart issues, similar-aged women without these issues, and healthy individuals for comparison. Women experiencing persistent chest pain, but without other major health issues like high blood pressure or diabetes, may be suitable for this study. As an unphased study, this trial offers participants the opportunity to contribute to groundbreaking research that could enhance understanding and treatment of heart conditions in women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this stress testing protocol is safe?

Research shows that the treatments tested in this study are generally safe. Here's a simple breakdown:

For altitude simulation, studies have found that people with stable heart conditions can handle high altitudes up to 3500 meters without major problems, suggesting that altitude simulation might be safe in this situation.

Handgrip exercises also look promising. Research indicates that a stronger handgrip links to a lower risk of heart disease and stroke, meaning that handgrip exercises are not only safe but could also benefit heart health.

Leg exercises, often used in stress tests, are generally safe with very few serious issues. According to the American Heart Association, the chance of a serious problem is only about 0.04%, indicating that leg exercises in stress tests are usually well-tolerated.

Overall, these activities seem safe based on previous research. However, it's always important to discuss any concerns with the trial team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to assess coronary heart disease using stress testing techniques like altitude simulation, handgrip exercises, and leg exercises. Unlike traditional stress tests that often involve treadmill or pharmacological methods, these techniques could offer more personalized and varied approaches to understanding cardiovascular health, especially in women with microvascular disease. By simulating different types of physical stress, this protocol may provide more comprehensive insights into how the heart functions under various conditions, potentially leading to more tailored and effective treatment strategies.

What evidence suggests that this stress testing protocol is effective for coronary heart disease?

This trial will evaluate different stress testing protocols for coronary heart disease. Research has shown that high-altitude environments can affect heart health by altering heart function, particularly in the small blood vessels, similar to microvascular coronary dysfunction (MCD). This helps researchers understand how MCD impacts the heart's ability to relax. Participants in this trial may undergo altitude simulation as part of the study.

Handgrip exercises are linked to a lower risk of heart disease. Studies indicate that a stronger handgrip is associated with fewer heart problems, suggesting that handgrip exercises might benefit heart health. Some participants in this trial will perform handgrip exercises to assess their impact on heart health.

Leg exercises are often used to test heart function and can help diagnose coronary artery disease. Exercise stress tests effectively evaluate heart performance during physical activity and can reveal hidden heart issues. This makes leg exercises an important tool for assessing heart health, especially in individuals who might have heart problems. Participants in this trial may undergo leg exercise stress tests to evaluate their heart function. ^{5 6 7 8 9}

Who Is on the Research Team?

Michael Nelson, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for men and women over 18 who fully understand and agree to the study's procedures. It excludes pregnant women, those unable to consent, with a history of heart/lung/brain diseases, high blood pressure, diabetes, metal implants or claustrophobia (which affects MRI testing), adherence issues, or animal dander allergies.

Inclusion Criteria

Understanding and willing to sign consent form.

Fully understanding and willing to undergo study procedures

Exclusion Criteria

I am currently pregnant.

You are allergic to animal fur or hair.

Your blood pressure is consistently higher than 140/90 mmHg when sitting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stress Testing

Participants undergo a series of stress maneuvers in conjunction with advanced cardiac magnetic resonance imaging

1-2 weeks

Multiple visits for stress testing and imaging

Follow-up

Participants are monitored for safety and effectiveness after stress testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Altitude simulation
• Handgrip
• Leg exercise

Trial Overview The study tests how different 'stress' activities like handgrip exercises, leg exercises, and altitude simulation affect small blood vessels in the heart using advanced cardiac MRI. It aims to better understand coronary microvascular dysfunction in women with chest pain but no large artery blockages.

How Is the Trial Designed?

Group I: calibration Experimental Treatment 3 Interventions

10 healthy individuals who will help to synchronize our imaging and stress testing maneuvers.

Group II: Women w/microvascular disease Experimental Treatment 3 Interventions

10 women with microvascular disease

Group III: Normal controls Experimental Treatment 3 Interventions

10 age-matched women with no evidence of microvascular disease

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

Atrial pacing and dipyridamole imaging are effective alternatives to traditional exercise stress testing for diagnosing coronary artery disease (CAD) in patients who cannot perform leg exercises, showing comparable results.

While the cold pressor test and isometric handgrip exercise have been explored, they have lower sensitivity for detecting CAD, indicating that more research is needed to validate other emerging testing methods like arm ergometry and beta-adrenergic agonist infusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of coronary artery disease in the patient unable to exercise: alternatives to exercise stress testing. Stratmann, HG., Kennedy, HL.[2019]

Exercise echocardiography is a highly effective noninvasive test for diagnosing coronary artery disease, outperforming exercise electrocardiography and showing comparable accuracy to perfusion scintigraphy, based on various stress-inducing methods.

This test not only helps in detecting coronary artery disease but also provides valuable insights for assessing heart function after procedures like angioplasty and heart surgery, and can predict outcomes after myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stress echocardiography--an evaluation of current status]. Schartl, M., Beckmann, S., Bocksch, W.[2016]

A comprehensive testing plan was developed for a 66-year-old man post-aortic dissection repair to assess his ability to safely return to high-intensity outdoor activities, including lifting, hiking, and scuba diving.

After tailored physiological testing and receiving an exercise prescription, the patient successfully engaged in his desired activities within 6 months without experiencing any adverse symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specificity of testing in a cardiac rehabilitation setting resulting in a patient's return to high-intensity outdoor activity following aortic dissection repair. Bartee, S., Shrestha, S., Ramos, B., et al.[2020]

A study involving six male firefighters undergoing phase II cardiac rehabilitation showed that high-intensity, occupation-specific training (HIOST) was safe, with no adverse arrhythmias or symptoms leading to discontinuation of the program.

The data collected from multiple HIOST sessions may provide more comprehensive insights into a patient's readiness to return to work compared to a single treadmill exercise stress test, which is the standard evaluation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity, occupation-specific training in a series of firefighters during phase II cardiac rehabilitation. Adams, J., Cheng, D., Berbarie, RF.[2021]

Exercise stress echocardiography (ESE) is a safe procedure for diagnosing coronary artery disease, with no reported deaths or serious complications like myocardial infarction during a study of 10,250 patients.

The most common complications were non-fatal cardiac arrhythmias, particularly supraventricular and ventricular extrasystoles, with advanced age and left atrial enlargement identified as predictors for these arrhythmias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography. Andrade, SM., Telino, CJ., Sousa, AC., et al.[2018]

Significant advancements have been made in understanding coronary atherosclerosis and assessing the risk and burden of atherosclerotic disease over the past 40 years.

Stress testing is a key method for identifying abnormalities in blood flow to the heart during physical or drug-induced stress, helping to diagnose myocardial ischemia effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic manipulation of coronary vascular physiology for the evaluation of coronary artery disease. Farhad, H., Murthy, VL.[2015]

Exercise testing is a crucial tool in medicine for evaluating various functions, particularly as a stress test for patients with coronary artery disease, helping to assess their heart health and overall functional capacity.

The article provides essential safety and performance guidelines for conducting exercise stress tests with electrocardiography, which are also applicable to other exercise testing methods like scintigraphy and echocardiography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise stress testing. Safety and performance guidelines. The Cardiac Society of Australia and New Zealand. [2004]

Exercise stress testing is a safe and effective non-invasive procedure for diagnosing and assessing various heart-related conditions, including arrhythmias and coronary heart disease.

Studies indicate that exercise stress tests supervised by trained health professionals have similar safety outcomes and effectiveness as those conducted by physicians, making it a viable alternative in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-physician-led exercise stress testing is a safe and effective practice. Sanford, KL., Williams, KM., Archbald, JA., et al.[2013]

Exercise testing is commonly used to assess the severity of chronic congestive heart failure (CHF) and the efficacy of treatments, but it has limitations in correlating exercise capacity improvements with actual mortality rates.

While drugs like ACE inhibitors can modestly improve exercise capacity in CHF patients, they are more effective in improving survival rates, suggesting that neuroendocrine activation may be a better indicator of patient outcomes than exercise performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing in heart failure. A critical review. Swedberg, K.[2018]

Stress echocardiography is an effective non-invasive diagnostic tool for coronary artery disease, utilizing various stress modalities to provoke myocardial ischemia and assess heart function through echocardiography.

The success of stress echocardiography relies on the cardiologist's specialized training and understanding of the patient's history and risk factors, which are crucial for determining the appropriate testing method and interpreting results accurately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coronary artery disease--diagnosis of ischaemia: general considerations. Schröder, K., Schultheiss, HP.[2019]

This review highlights the importance of exercise stress testing in evaluating coronary heart disease, discussing both the advantages and disadvantages of various testing methods, which can help clinicians make informed decisions in practice.

The paper emphasizes the need to interpret stress test results carefully, particularly regarding false positives and negatives, and suggests subgrouping patients based on their results to improve clinical relevance and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise stress testing--current status. Bartel, AG.[2018]

Stress testing is essential for diagnosing and managing coronary artery disease, particularly in assessing prognosis and evaluating therapy responses, but is not needed when angina is clinically evident.

The exercise treadmill test remains the most common method for stress testing, and its accuracy can be enhanced with imaging agents or alternative pharmacologic agents for patients unable to exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating coronary artery disease noninvasively--which test for whom? Chou, TM., Amidon, TM.[2018]

A comprehensive study involving 50,000 exercise stress tests across 20 clinical physiology departments in Sweden found that the overall complication rate was low at 18.4 per 10,000 tests, with a mortality rate of only 0.4 per 10,000 tests, indicating that exercise stress testing is generally safe even for very ill patients.

Patients with aortic stenosis were identified as having a higher risk for complications during testing, highlighting the importance of careful patient selection and monitoring during exercise stress tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing: a prospective study of complication rates. Atterhög, JH., Jonsson, B., Samuelsson, R.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408258/

Inverse association between pre-high-altitude potassium ... High-altitude hypoxia is known to impair cardiac microvascular function, a pathophysiological state recognized as coronary microvascular disease ...

2. nature.com nature.com/articles/s41598-024-51202-8

Machine learning-based prediction model for myocardial ... High altitude exposure increases the risk of myocardial ischemia (MI) and subsequent cardiovascular death. Machine learning techniques have ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223008016

Coronary microvascular dysfunction and cardiovascular ... Studies have shown that CMD is closely related to a variety of cardiovascular diseases, can aggravate the occurrence and development of cardiovascular diseases.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8197622/

Impact of High Altitude on Cardiovascular Health: Current ... Faeh and colleagues reported respective 22% and 12% reductions in mortality from coronary heart disease and stroke per 1000 m gain in elevation.

5. karger.com karger.com/ger/article/doi/10.1159/000545848/925716/The-impact-of-moderate-altitude-on-manifestations

The Impact of Moderate Altitude on Manifestations ... Conclusions. Altitude exposure reduces oxygen availability, which can be detrimental to patients at high risk of CAD or with established disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1860700/

Safety and exercise tolerance of acute high altitude ... Abstract. Objectives. To assess the safety and cardiopulmonary adaptation to high altitude exposure among patients with coronary artery disease.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10092947/

Coronary Syndromes and High-Altitude Exposure—A ... Patients with stable coronary artery disease on optimal treatment and in a good physical condition can tolerate traveling to high altitude up to 3500 m.

8. nature.com nature.com/articles/s41598-024-79735-y

Nomogram models for predicting myocardial ischemia ... We have successfully established two nomogram models to predict myocardial ischemia under high-altitude exposure and identified some risk factors.

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.122.012568

Coronary Microvascular Disease in Contemporary Clinical ... This review describes the clinical implications of CMD and relevant invasive methods for CMD assessment in the cardiac catheterization laboratory.